Vaginal prolapse occurs when the bladder, uterus and/or bowel protrude into the vagina, typically due to loss of natural support for the pelvic organs and the vaginal vault. Vaginal prolapse occurs most often in women who have undergone a prior hysterectomy, however prolapse may also occur in women who still have a uterus.
In the normal female anatomy, direct support for the vaginal vault is provided by the parametrium (cardinal and uterosacral ligaments) and paracolpium fibers. These fibers act like suspensory ligaments and arise from the fascia of the piriformis muscle, sacroiliac joint and lateral sacrum. The fibers insert into the lateral upper third of the vagina. Indirect support for the vaginal vault is provided by the levator plate, formed by the fusion of the right and left levator ani muscles located between the rectum and coccyx. Pelvic organ prolapse and vaginal vault prolapse occurs after failure of these direct and indirect supporting mechanisms and is frequently accompanied by weakness of the muscular pelvic floor and suspensory fibers of the parametrium and upper paracolpium.
It has been reported that each year in the USA, approximately 200,000 women undergo surgery for pelvic organ prolapse and that 11.1% of women had undergone surgery for pelvic organ prolapse, urinary incontinence or both by age 80. Repeat surgery for recurrent prolapse was required in 29.2% within 4 years of the primary surgical procedure. Women less than 60 years of age and women with higher grades of prolapse seem to be more likely to experience recurrent prolapse after vaginal repair surgery. (Carey M. et al., Vaginal surgery for pelvic organ prolapse using mesh and a vaginal support device, BJOG, 2008, 115(3):391-397)
Pelvic organ prolapse is the symptomatic descent of one or more of components of the vaginal wall, including the anterior wall, posterior wall, and the vaginal apex, which could lead to descent of the cervix and uterus or the vaginal cuff following a hysterectomy. Nomenclature exists to describe the prolapse based on the pelvic organ that has herniated into the vaginal wall. Anterior defects with herniation of the urinary bladder into the vagina creates a cystocele. A retocele occurs from posterior vaginal wall defects, particularly from the rectum bulging into the vagina. A hysterocele occurs when the uterus descends into the vagina thus resulting in a vaginal vault descent. Apical defects include uterine prolapse or uterovaginal prolapse, vaginal cuff prolapse after hysterectomy, and enteroceles. An enterocele is protrusion of the intestines into the apical vaginal wall and can be in either the anterior or posterior compartment.
There are a variety of surgical techniques that may be used to repair pelvic organ prolapse, including vaginal, abdominal and laparoscopic approaches, with each approach having advantages and disadvantages in light of the others.
Sacrocolpopexy is a surgical technique for repairing pelvic organ prolapse, specifically apical or vaginal vault prolapse in women. Vaginal vault prolapse may occur in women who have had a hysterectomy. Vaginal vault prolapse occurs when the vagina descends from its normal position, sometimes out through the vaginal opening. Sacrocolpopexy is generally performed on women who have had a hysterectomy and thus the uterus and cervix are removed.
Generally, reconstruction is accomplished through open abdominal surgery or through minimally invasive surgery such as laparoscopy or robotic-assisted techniques. The technique involves suspending the vaginal apex to the sacral promontory so as to recreate the natural anatomic support that is normally provided by the uterosacral and cardinal ligaments. In treating vaginal vault prolapse, support of the pelvic organs is generally achieved by attaching a piece of material, such as mesh, usually from the top and back of the vagina to a ligament of the lower backbone. Mesh may be attached to the apex of the vagina as well as to the anterior and/or posterior wall.
Abdominal sacrocolpopexy is associated with a lower rate of recurrent vault prolapse, reduced grade of residual prolapse, longer time to recurrence, and less dyspareunia compared with the vaginal procedures, such as sacrospinous ligament fixation and uterosacral ligament suspension. (Rosati, M. et al., Efficacy of Laparoscopic Sarcocervicopexy for Apical Support of Pelvic Organ Prolapse, J Soc Laparoendoscopic Surgeons, 2013, 17(2):235-244)
Laparoscopic sacrocolpopexy aims to bridge the gap between the abdominal and vaginal procedures to provide the best outcomes of abdominal sacrocolpopexy with decreased morbidity similar to vaginal procedures. Although sacrocolpopexy, which is performed by interposing a synthetic mesh between the vaginal cuff and the bone, is effective, it is associated with a mesh erosion rate between 0.8% and 9%. (Rosati 2013)
Sacrocervicopexy is a procedure similar to sacrocolpopexy, in which a graft material is used to suspend the cervix to the anterior longitudinal ligament of the sacrum. The technique is normally performed laparoscopically by attaching synthetic mesh to the front and back of the vagina and subsequently to the sacrum. It has generally been used to treat uterovaginal prolapse in women having a cervix and desiring to preserve their uterus and fertility. Sacrocervicopexy can be performed either with uterine preservation or after supracervical hysterectomy and may avoid the risk of mesh erosion while preserving the integrity of the uterosacral and cardinal ligaments, which are the main supports of the vaginal apex. It may be associated with vaginal surgery (colporraphy) in all cases of concomitant anterior or posterior prolapse. (Rosati 2013)
Prior art devices have generally been vaginal stents/support devices that resemble a solid rounded cylinder-like device. These vaginal support devices having a rounded surface made it very difficult to affix the mesh to the vagina.
What is needed is a vaginal support device and system capable of providing a flat surface for affixing the mesh and facilitating the placement and affixing of mesh to treat pelvic organ prolapse.